ultrasonic cutting hemostatic knife handle

Abstract

This invention relates to a blade holder for an ultrasonic cutting hemostatic knife. Its main body is the blade holder, which is divided into a replacement part and a fixing part, which are detachable and detachable. Compared with previous technologies, the advantages of this invention are: (1) The replacement part and fixing part of the blade holder are detachable structures, allowing for separate production, resulting in a simple structure, convenient manufacturing, and suitability for mass production; (2) The replacement part of the blade holder is for single use, while other parts of the blade head can be repeatedly sterilized and reused, reducing the burden on doctors and patients; (3) The detachable structure of the replacement part and fixing part of the blade holder improves the flexibility of intraoperative replacement.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a blade holder for an ultrasonic cutting hemostatic knife. Background Technology

[0002] Ultrasonic surgical devices can cut tissue and achieve hemostasis through coagulation, thereby completing the cutting and sealing of tissue and advantageously minimizing patient trauma. An ultrasonic surgical device includes an ultrasonic transducer and a blade connected to the transducer. The blade includes a distally mounted end effector that can grasp tissue. The end effector is typically connected to a handle and / or robotic surgical tool via a blade shaft. The blade is acoustically coupled to the transducer via a waveguide extending through an axis. Ultrasonic surgical devices with these properties can be used for open surgical purposes, laparoscopic or endoscopic surgical procedures, including robot-assisted surgery.

[0003] In existing technologies, the shank of ultrasonic cutting hemostatic knives is usually formed by CNC machining, and even bending processes are added. In order to meet the requirements of coaxiality and performance, multiple clamping is required, resulting in low production efficiency, limited production capacity, and high manufacturing costs.

[0004] Existing cutting heads have the following defects:

[0005] 1. The curved section of the tool holder has a large curvature and contains fine features, resulting in poor machining consistency and significant differences in amplitude output. Furthermore, material or machining issues can easily lead to tool breakage during operation, with the majority of breakage occurring at the curved section of the tool holder head, rendering it unusable and resulting in waste.

[0006] 2. Long machining time, high scrap rate, and high production cost;

[0007] 3. Due to the difficulty in sterilizing the blade, it is required to be used only once, increasing the cost of use. The blade assembly mainly consists of the blade shaft, shock-absorbing sleeve, inner / outer sleeve, support spring assembly, and clamp head. Currently, there are four main areas on the blade that are difficult to sterilize effectively: 1. where the shock-absorbing sleeve covers the blade shaft; 2. where the inner sleeve covers the blade shaft; 3. where the outer sleeve covers the inner sleeve; 4. where the clamp head is located. Summary of the Invention

[0008] The purpose of this invention is to provide a blade holder for an ultrasonic cutting hemostatic knife that allows for component replacement.

[0009] The present invention is achieved through the following technical solution: a blade rod for an ultrasonic cutting hemostatic knife, the main body of which is a blade rod 1, the blade rod 1 is divided into a replacement part 11 and a fixing part 12, the replacement part 11 and the fixing part 12 are detachable and detachable.

[0010] Compared with previous technologies, the beneficial effects of the present invention are as follows:

[0011] (1) The replacement part and the fixing part of the tool holder are detachable structures, which can be produced separately. The structure is simple, easy to manufacture, and suitable for mass production.

[0012] (2) The replacement part of the blade holder is for single use, while other parts of the blade head can be disinfected and reused, reducing the burden on medical staff and patients;

[0013] (3) The replacement and fixing parts of the scalpel are detachable, which can improve the flexibility of replacement during the operation.

[0014] (4) The material requirements for the fixing part are reduced, and other lower-cost materials can be used to make it, which can reduce the overall production cost of the product. Attached Figure Description

[0015] Figure 1 This is a side sectional view of Embodiment 1, showing the replacement part and the fixing part;

[0016] Figure 2 This is a side sectional view of another structure in Embodiment 1 of the replacement and fixing parts;

[0017] Figure 3 This is a side sectional view of Embodiment 2, showing the replacement part and the fixing part;

[0018] Figure 4 This is a structural schematic diagram of the replacement part and the fixing part in Embodiment 5;

[0019] Figure 5 A schematic diagram showing the structure with grooves added to the replacement and fixing parts;

[0020] Figure 6 This is a schematic diagram of the structure of the overmolded portion in Example 7;

[0021] Figure 7 for Figure 6 The combined effect diagram;

[0022] Figure 8 This is a schematic diagram of the structure of the overmolded portion in Example 8;

[0023] Figure 9 for Figure 8 The combined effect diagram;

[0024] Figure 10 This is a schematic diagram of the structure of the encapsulated portion in Example 9;

[0025] Figure 11 for Figure 10 The combined effect diagram;

[0026] Figure 12 This is a schematic diagram of the structure for the resonance amplitude of the tool holder.

[0027] Labeling Explanation: 1-Tool holder, 11-Replacement part, 111-Bent rod B, 112-Straight rod B, 12-Fixing part, 121-Straight rod A, 13-External thread section, 14-Screw, 15-Groove, 2-Glue coating, 21-Bent rod glue coating, 22-Straight rod glue coating, 23-Hook-shaped glue coating, 24-Protruding glue coating, 25-Toothed glue coating A, 26-Toothed glue coating B. Detailed Implementation

[0028] The present invention will now be described in detail with reference to the accompanying drawings:

[0029] like Figure 1-12 As shown: the blade of the ultrasonic cutting hemostatic knife has a blade 1 as its main body. The blade 1 is divided into a replacement part 11 and a fixing part 12. The proximal end of the fixing part is connected to the ultrasonic cutting hemostatic knife. The replacement part 11 and the fixing part 12 are detachable and detachable.

[0030] Depending on the type of disassembly and assembly structure of the replacement part 11 and the fixing part 12, the following embodiments can be derived:

[0031] Example 1

[0032] like Figure 1 , 2 As shown: The near end of the replacement part 11 is provided with an external thread section 13, and the far end of the fixing part 12 is provided with a threaded hole that mates with the external thread section 13.

[0033] Both use matching thread specifications to ensure effective engagement. Figure 1 In actual production, it is advisable to place the threaded hole near the end of the replacement part 11 and the external thread section 13 at the far end of the fixing part 12. Figure 2 ).

[0034] Example 2

[0035] like Figure 3 As shown: The present invention also includes a screw 14, a bent rod threaded hole is provided at the proximal end of the replacement part 11, and a straight rod threaded hole is provided at the proximal and distal ends of the fixing part 12.

[0036] Example 3

[0037] The replacement part 11 and the fixing part 12 are connected by an adhesive. The adhesive can be medical quick-drying glue, metal glue, fastening glue, or epoxy resin, etc.

[0038] Based on the shapes of the fixing part and the replacement part, the following embodiments can be derived:

[0039] Example 4

[0040] Based on embodiments 1-3, the fixing part is a straight rod A; the replacement part 11 is a bent rod A. In this embodiment, it is equivalent to only replacing the bent part. (See...) Figure 1-3 )

[0041] Example 5

[0042] like Figure 4 As shown: Based on embodiments 1-3, the fixing part is a straight rod A121; the replacement part 11 includes a bent rod B111 and a straight rod B112 fixedly connected to the proximal end of the bent rod B111. Here, it is equivalent to having a straight rod behind the bend. Compared with embodiment 4, this embodiment has a shorter length of the straight rod A for the same specification tool holder.

[0043] Example 6

[0044] like Figure 5 As shown: Based on embodiments 1-5, the replacement part 11 and / or the fixing part 12 are provided with a clamping groove 15. This can serve as a clamping position for the disassembly and assembly tools, effectively preventing slippage.

[0045] Furthermore, an adhesive coating is provided at the connection between the replacement part 11 and the fixing part 12. This adhesive coating serves to support the replacement part 11 and also provides a seal.

[0046] Depending on the type and structure of the overmolding, the following examples can be derived:

[0047] Example 7

[0048] like Figure 6 , 7 As shown: The coating includes a curved rod coating 21 located near the replacement part 11 and a straight rod coating 22 located at the far end of the fixing part 12. The straight rod coating 22 and the curved rod coating 21 are symmetrical to each other and can be connected to each other.

[0049] Example 8

[0050] like Figure 8 , 9 As shown: The coating includes a hook-shaped coating 23 located near the end of the replacement part 11 and a raised coating 24 located at the far end of the fixing part 12. The hook-shaped coating 23 and the raised coating 24 cooperate with each other to connect the replacement part 11 and the fixing part 12.

[0051] Example 9

[0052] like Figure 10 , 11As shown: the toothed rubber ring is provided at the proximal end of the replacement part 11, and the toothed rubber ring is provided at the distal end of the fixing part 12. The toothed rubber ring A25 and the toothed rubber ring B26 are rotationally symmetrical. The toothed rubber ring A25 and the toothed rubber ring B26 are connected to each other so that the replacement part 11 and the fixing part 12 are connected to each other.

[0053] Furthermore, the tool holder also includes a shock-absorbing coating, which is located at the node where the axial amplitude curve of the tool holder intersects the zero displacement reference line. The plane containing these nodes contains points with zero displacement tendency; the maximum amplitude occurs at the tip of the tool holder. Additionally, placing the connection between the replacement part 11 and the fixing part 12 at the node where the axial amplitude curve of the tool holder intersects the zero displacement reference line is optimal. In this case, the clamping at the connection is equivalent to the shock-absorbing coating.

[0054] like Figure 12 As shown:

[0055] The resonant amplitude at any point on the tool holder can be represented by the following sine curve:

[0056] Disp. = A·sin(ω·t)

[0057] Where: A is the zero-peak value of the amplitude, ω = 2·π·f, f is the resonant frequency, and t is the instantaneous time of the vibration.

[0058] During the process of clamping tissue, the shank of the cutter is subjected to radial bending moment. Therefore, it is necessary to set an elastic support between the node and the inner sleeve to reduce the attenuation during the ultrasonic transmission process and to ensure that the front support can also play a sealing role.

[0059] Rubber coating (shock-absorbing rubber coating) is located in Figure 12 The four zero-displacement positions (I, II, III, IV) minimize amplitude and connection loss caused by the rubber coating, effectively isolating the contact friction between the tool holder and the inner sleeve. The actual position and amount of rubber coating can be adjusted as needed based on the tool holder length specifications.

[0060] Furthermore, the replacement part 11 can be produced using powder metallurgy, which mainly includes four processes: conventional method, metal injection molding (MIM), metal 3D printing (AM), and isostatic pressing (IP).

[0061] Taking the metal 3D printed replacement part 11 as an example:

[0062] Metal 3D printing technology utilizes the rapid melting and solidification of metal powder under the thermal effect of a laser beam. To completely melt the metal powder, a laser energy density exceeding 10 is required. 6 W / cm 2Currently used lasers mainly include Nd-YAG lasers, Co2 lasers, and fiber lasers. These lasers produce wavelengths of 1064nm, 10640nm, and 1090nm, respectively. Metal powders have a higher absorption rate for shorter wavelength lasers such as 1064nm, but a lower absorption rate for longer wavelength lasers such as 10640nm. Therefore, in the process of forming metal parts, shorter wavelength lasers have higher laser energy utilization, while using longer wavelength Co2 lasers results in lower laser energy utilization.

[0063] Metal 3D printing technology allows metal powder to be completely melted under the action of a high-energy laser. After heat dissipation and solidification, it is metallurgically welded to the base metal, and then layer by layer to form the desired three-dimensional solid. The surface roughness of the formed parts is usually Ra4-5, and the tensile strength is comparable to that of titanium of the same size. It can also improve the gripping effect of instruments on tissues. It can also be post-processed and polished to Ra0.4 or even 0.1 to meet the requirements of conventional machining for the parts. In addition, the forming direction during printing can be controlled to be perpendicular to the axis of the replacement part 11 for layer-by-layer additive manufacturing. This can effectively suppress the lateral vibration component of the tool holder during operation, improve energy conversion efficiency and effective amplitude output, reduce fatigue stress and heat generation during operation, extend service life, and is suitable for mass production, improving material utilization, reducing scrap loss, and lowering costs.

[0064] In conventional 3D printing solutions, additive manufacturing is carried out in horizontal layers. However, for the replacement part 11, its axis is in the direction of sound transmission. Horizontal layer additive manufacturing will result in the material being layered in the horizontal direction due to the printing and cooling sequence. In this embodiment, a normal plane perpendicular to the axis can be selected as the layer for additive manufacturing. Furthermore, by adjusting the printing parameters according to the normal plane, a suitable gradient material can be manufactured to ensure a continuous transition of acoustic parameters such as density and elastic modulus of the replacement part, thereby reducing the overall acoustic impedance. The fixed part has a low stress level and a simple structure, which relaxes the requirements for material consistency and stability. Alternative domestic materials can be selected to reduce dependence on imported materials and expand the range of material choices.

[0065] The scope of application of the blade described in this case includes, but is not limited to, high-energy ultrasonic medical devices such as ultrasonic cutting and hemostatic knives, ultrasonic bone knives, ultrasonic suction knives, ultrasonic debridement knives, and ophthalmic phacoemulsification needles.

[0066] Although the present invention has been illustrated and described through specific embodiments and alternative methods, it should be understood that various changes and modifications may be made without departing from the spirit and scope of the invention. Therefore, it should be understood that the present invention is not limited in any sense except by the appended claims and their equivalents.

Claims

1. A blade holder for an ultrasonic cutting hemostatic knife, the main body of which is a blade holder (1), characterized in that: The blade (1) is divided into a replacement part (11) and a fixing part (12). The proximal end of the fixing part is connected to the handle of the ultrasonic cutting hemostatic knife. The replacement part (11) and the fixing part (12) are detachable and detachable. A connecting adhesive (2) is provided at the connection between the replacement part (11) and the fixing part (12); The tool holder also includes multiple shock-absorbing rubber coatings, and the connecting rubber coating (2) and multiple shock-absorbing rubber coatings are located at all nodes where the axial amplitude curve of the tool holder intersects with the zero displacement baseline.

2. The handle of the ultrasonic cutting hemostatic knife according to claim 1, characterized in that: The replacement part (11) has an external thread section (13) at its proximal end, and a threaded hole that mates with the external thread section (13) is provided at the distal end of the fixing part (12).

3. The handle of the ultrasonic cutting hemostatic knife according to claim 1, characterized in that: It also includes screws (14), with a bent rod threaded hole at the proximal end of the replacement part (11) and a straight rod threaded hole at the proximal and distal ends of the fixing part (12).

4. The handle of the ultrasonic cutting hemostatic knife according to claim 1, characterized in that: The replacement part (11) and the fixing part (12) are connected by an adhesive.

5. The handle of the ultrasonic cutting hemostatic knife according to any one of claims 1-4, characterized in that: The fixing part (12) is a straight rod A (121), and the replacement part (11) is a bent rod A, or the replacement part (11) includes a bent rod B (111) and a straight rod B (112) fixedly connected to the near end of the bent rod B (111).

6. The handle of the ultrasonic cutting hemostatic knife according to any one of claims 1-4, characterized in that: The replacement part (11) and / or the fixing part (12) are provided with a groove (15) for clamping.

7. The handle of the ultrasonic cutting hemostatic knife according to claim 1, characterized in that: The connecting rubber coating (2) includes a curved rod rubber coating (21) located near the replacement part (11) and a straight rod rubber coating (22) located far from the fixing part (12). The straight rod rubber coating (22) and the curved rod rubber coating (21) are symmetrical to each other and can be connected to each other.

8. The blade holder for the ultrasonic cutting hemostatic knife according to claim 1, characterized in that: The connecting coating (2) includes a hook-shaped coating (23) located at the proximal end of the replacement part (11) and a raised coating (24) located at the distal end of the fixing part (12). The hook-shaped coating (23) and the raised coating (24) cooperate with each other to connect the replacement part (11) and the fixing part (12).

9. The handle of the ultrasonic cutting hemostatic knife according to claim 1, characterized in that: The connecting coating (2) includes a toothed coating A (25) surrounding the proximal end of the replacement part (11) and a toothed coating B (26) surrounding the distal end of the fixing part (12). The toothed coating A (25) and the toothed coating B (26) are rotationally symmetrical. The toothed coating A (25) and the toothed coating B (26) are connected to each other so that the replacement part (11) and the fixing part (12) are connected to each other.

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